PHARMO Institute Seroquel Safety Study

Schizophrenia Clinical Trial

— PHARMO II  

Official title:

Seroquel Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342120
• Other study ID #: D1443L00085
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: August 31, 2011
• Start date: September 2010
• Est. completion date: November 2010

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)
• Study type: Observational

Clinical Trial Summary

The purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts, extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and stroke. This retrospective cohort study is based on population-based record linkage system (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18325
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Episode of new use of atypical antipsychotics in naïve (not used antipsychotic drugs for a year) users of antipsychotics.

Exclusion Criteria:

• less than a year of recorded history before the cohort entry date

• use of multiple antipsychotics concomitantly

• duration and dose of the antipsychotic drug cannot be determined

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anxiety Disorders
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Generalized Anxiety Disorder
• Major Depressive Disorder
• Schizophrenia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	PHARMO Institute for Drug Outcomes Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The outcomes of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine vs corresponding incidence rates in users of comparison drugs			Yes